Services for validated systems and qualified equipment.
QMVP supports computerized system and software validation (CSV/CSA), qualification and validation (CQV) of production systems and equipment, and the assessment and validation of AI systems in GxP environments.Find the right support for your project.
CSV/CSA
Computerized system and software validation (CSV/CSA)
Risk-based validation of new or modified systems and software and assessment of the validated state across the system lifecycle.Validation strategy and delivery
CSV & CSAValidate computerized systems using a risk-based approach
QMVP supports risk-based computerized system validation – from validation strategy and user requirements through risk-based testing and traceability to the validation report.
Typical starting points: New system · Process change · Change ControlExplore this serviceSaaS & CloudValidate SaaS and cloud applications using a risk-based approach across the system lifecycle
QMVP helps define operator and service provider responsibilities and assess supplier evidence, changes, releases and required revalidation activities using a risk-based approach.
Typical starting points: New system · Change Control · Client auditExplore this serviceOperation and system lifecycle
Periodic ReviewAssess the validated state of computerized systems through periodic review
QMVP assesses changes, deviations, incidents, access rights, data integrity and operational and supplier evidence to establish a traceable basis for required actions or revalidation.
Typical starting points: Periodic Review · Upcoming audit · CAPA / FindingExplore this serviceData integrity and controls
Data integrity & audit trailsReview data integrity, access rights and audit trails using a risk-based approach
QMVP assesses GxP-relevant data flows, roles and access rights, audit trail functions and review processes using a risk-based approach and documents unmet requirements and required actions.
Typical starting points: Upcoming audit · Regulatory inspection · CAPA / FindingExplore this serviceAI
Assessment and validation of AI systems in GxP environments
A dedicated service area for assessing AI use, data and model evidence, and validating AI-supported systems.AI use, implementation and operation
AI systemsAssess and validate AI systems in GxP environments
QMVP supports the assessment and validation of AI-supported systems – from the use case and data quality through AI model testing and system validation to human oversight, monitoring and change management.
Typical starting points: New AI application · AI functionality in an existing system · Model or provider changeExplore this serviceCQV
Qualification and validation (CQV) – production systems and equipment
Qualification of new or modified production and laboratory equipment, including periodic assessment and requalification.Production and laboratory equipment
Production equipmentQualify production systems and equipment using a risk-based approach
Direct technical support from user requirements and qualification strategy through DQ, IQ, OQ and PQ to a traceable final report.
Typical starting points: New equipment · Process change · Change ControlExplore this serviceLaboratory equipmentQualify laboratory equipment using a risk-based approach
From defining the risk-based qualification scope through the required testing and deviation assessments to the qualification report.
Typical starting points: New laboratory equipment · Requalification · Documentation gapExplore this serviceTemperature-controlled systems and areas
Temperature-controlled systemsQualify temperature-controlled systems and areas using a risk-based approach
From refrigerators and freezers to incubators, environmental chambers and temperature-controlled storage and production areas: QMVP supports temperature mapping, sensor placement, data analysis, deviation assessment and qualification documentation.
Typical starting points: New equipment · Requalification · Change ControlExplore this servicePeriodic assessment and requalification
Periodic assessmentAssess and maintain the qualified state of production systems and equipment with traceable evidence
QMVP assesses changes and existing evidence, derives a risk-based scope and supports periodic assessments, requalification and revalidation.
Typical starting points: Requalification · Upcoming audit · Change ControlExplore this serviceAcross disciplines
Project modules for CSV/CSA and CQV
These services connect computerized system validation with the qualification and validation of production systems and equipment.Planning, review and standards
Project planningClear planning for your validation project
QMVP works with you to prepare a risk-based Validation Master Plan (VMP) as a clear, practical basis for your validation and qualification project.
Typical starting points: New system · New equipment · Process changeExplore this serviceTechnical document reviewReview validation and qualification documents before an audit or inspection
Receive a traceable gap list, direct technical feedback and targeted corrective actions for the remaining preparation time.
Typical starting points: Upcoming audit · Regulatory inspection · Documentation gapExplore this serviceProcesses & templatesMake validation processes and templates lean, consistent and risk-based
QMVP reviews existing validation processes and controlled document templates, reduces unnecessary complexity and aligns scope and detail with the relevant system risks.
Typical starting points: CAPA / Finding · Documentation gap · Growth / scalingExplore this serviceNext step
